Addressing threats to health care's core values, especially those stemming from concentration and abuse of power. Advocating for accountability, integrity, transparency, honesty and ethics in leadership and governance of health care.

Monday, January 18, 2010

Not Just an American Disease

We have written about attacks on rigorous evidence-based medicine, and particularly on comparative effectiveness research from those with vested interests in having clinical research come out a certain way (e.g., see this most recent relevant post). Those who see such research primarily as a marketing opportunity tend to be offended by the notion of rigorous, unbiased research that may not be so easily turned to marketing purposes. Since I, like the other current Health Care Renewal bloggers, am based in the US, we tend to focus on local examples. But it turns out that the American malady described above has spread to Germany.

A long-running feud between pharmaceutical companies and the German institute that evaluates the effectiveness of medical treatments could cost the institute director his job. Although the post is supposed to be apolitical, members of Germany’s new coalition government have called for Peter Sawicki, founding director of the Institute for Quality and Efficiency in Health Care (known by its German acronym IQWiG, pronounced ICK-vig), to be replaced with someone who is friendlier to the pharmaceutical industry. The institute’s board of directors are expected to decide on 20 January whether Sawicki, a clinical researcher and diabetes expert, will be replaced when his contract runs out later this year.

Sawicki’s supporters say the move would endanger the institute’s reputation for impartial and rigorous science, and earlier this month a petition signed by 600 doctors and clinical researchers called on the health minister and the board to keep Sawicki on. Gerd Antes, director of the German Cochrane Centre in Freiburg, a not-for-profit organization that analyzes health care effects, says that replacing Sawicki would significantly undermine IQWiG and its work. Antes views the anti-Sawicki push as 'part of the political game to soften and to weaken rigorous procedures for new drugs and medical devices in Germany.'

And it turns out that the American-based pharmaceutical industry has jumped right in.

Big pharma’s attacks have even come from outside Germany. In March 2009, the Pharmaceutical Research and Manufacturers of America petitioned the Obama Administration to put Germany on a trade and intellectual property 'priority watch list' chiefly because of IQWiG’s influence on the German drug market. The petition complained that the institute has 'inadequately taken into account the value of innovative pharmaceuticals,' among other complaints. The Obama Administration declined to put Germany on its watch list.

Parenthetically, "innovation" seems to be a favorite term that those with vested interests in selling products or services use to describe those products, sometimes in the absence of any data that shows them to be superior to the alternatives in terms of important clinical outcomes, that is, outcomes that patients may care about. "Innovative" was also how complex financial products which contributed to the global economic meltdown were described by those who stood to make money selling, or sometimes simultaneously short-selling them, - but maybe that's guilt by association.

I hope the Germans are able to preserve their stake in honest, comparisons of tests and treatments that are not influenced by those with vested interests in selling those tests and treatments.

The corruption of evidence-based research by the pharmaceutical companies is really a short term view on their part that neglects that value that knowledge generation has to their industry.

The pharmaceutical companies benefit enormously from knowledge transfer from publicly funded institutions as well as partnering efforts so good science aside, it is not a wise business decision to interfere with the generation of knowledge by these institutions.

Reading this post I could not help but think of a side comment made by a doctor last week in a private conversation. This practice serves mostly welfare patients, and schedules 50 patients per day.

The doctor was happy that there is a new front end covering all the various insurance programs. They were not happy spending 20 minutes explaining to a non-doctor why they needed a MRI as this cuts down on production. They were equally unhappy with the generics first policy of the government run programs since generics are junk. They wanted to return to the old days when they had a closer relationship with their drug reps.

This doctor feels they can work at this level, their decisions cannot be questioned, and they should have unlimited access to the latest in drugs and testing.

My reality as a business person is that if we are to bend the health care cost curve questions need to be asked. Generics are often made in the same facilities as branded drugs. Drug reps are salespeople and have no medical training or interest in comparative testing.

Doctors are smart people. Part of the problem, from my perspective, is that ego and work pressures have produced a working group that feel they are above reproach. They will run all of the labs possible since this is easier than selecting those items necessary for this patient. Being a “good” doctor is measured in the number of patients seen per day. Being a “good” doctor is also measure in prescribing only the latest patented medicines.

All of the above plays into pharma’s hand as it help drive prescriptions and thus profits.

The German medical system is already facing financial pressure. They need to look closely at who is calling for this change, the price of this change, and the ultimate question regarding any medical decision: How will this impact patients?

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